LCP 02.124.224Recalls & reported problems
Synthes GmbH · 3.5MM LCP PROXIMAL TIBIA PLATE LOW BEND 16 HOLES/232MM/RIGHT · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982042699), received between Oct 3, 2017 and Oct 3, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2017Break; Break
IT WAS REPORTED ON 09/15/2017 THAT ON (B)(6) 2017, PATIENT UNDERWENT HARDWARE REMOVAL SURGERY DUE TO NONUNION. THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2016 FOR OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR A PROXIMAL TIBIA FRACTURE USING DEPUY SYNTHES DEVICES. THE NONUNION CAUSED THE PROXIMAL TIBIA PLATE TO BREAK IN HALF WHILE THE SCREWS STAYED INTACT. THE REVISION PROCEDURE USED THE MEDICAL DEVICES OF SMITH AND NEPHEW (TIBIA PLATE AND SCREWS). THERE WAS NO SURGICAL DELAY, NO FRAGMENTS GENERATED FROM BROKEN DEVICE, NO ADDITIONAL MEDICAL INTERVENTION OR X-RAYS REQUIRED. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES ONE PART CONCOMITANT PARTS: SCREWS(PART NUMBER: 212.115, LOT NUMBER UNKNOWN, QUANTITY: 1), (PART NUMBER: 212.129, LOT NUMBER UNKNOWN, QUANTITY: 1) (PART NUMBER: 212.112, LOT NUMBER UNKNOWN, QUANTITY: 2), (PART NUMBER: 212.239, LOT NUMBER UNKNOWN, QUANTITY: 2), (PART NUMBER: 212.330, LOT NUMBER UNKNOWN, QUANTITY: 1), (PART NUMBER: 02.200.030, LOT NUMBER UNKNOWN, QUANTITY:1) THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 6911607 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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